UPDATED Public Health Alert: Counterfeit Alli containing sibutramine

1/23/2010The U.S. Food and Drug Administration (FDA) is updating its warning to the public about a counterfeit version of Alli 60 mg capsules (120 count refill pack) being sold over the internet, particularly at online auction sites. FDA advises people who believe that they have a counterfeit product not to use the drug.

Alli is an FDA-approved over-the-counter weight loss drug that contains orlistat as its active ingredient. The counterfeit version of Alli does not contain orlistat; rather, it is made with varying amounts of sibutramine, a stimulant drug.

Although sibutramine is the active ingredient in another FDA-approved prescription weight loss drug, it is only to be used in specific doses and under the supervision of a physician. The counterfeit product is illegal and unsafe.

Additional FDA laboratory tests on the counterfeit product show that people may be taking 3-times the usual daily dose (or twice the recommended maximum dose) of sibutramine if they are following the dosing directions for Alli. Healthy people who take this much sibutramine can experience anxiety, nausea, heart palpitations, tachycardia (a racing heart), insomnia, and small increases in blood pressure. This excessive amount of sibutramine is dangerous to people who have a history of cardiovascular disease, and can lead to elevated blood pressure, stroke, or heart attack.

FDA recommends everybody check and make sure they are not taking counterfeit Alli. If they suspect they are taking the counterfeit product, they should stop taking the drug. People should contact their healthcare professionals if they have taken the counterfeit product and are experiencing more than mild side effects, especially if they have a history of cardiovascular disease.

Although the counterfeit product looks very similar to Alli, this product can be identified by:

An expiration date that includes a MONTH, DAY, and YEAR — the expiration date of the real product only contains a MONTH and a YEAR. Photo examples

A plain foil for the inner safety seal without any words on it — the safety seal of the real product has the words “SEALED FOR YOUR PROTECTION” prominently printed on it. Photo examples

The counterfeit product will also contain large capsules with white powder, as opposed to the small white pellets found in Alli. Photo examples

People can also compare the product they bought over the internet to one purchased at a pharmacy. The plastic bottle of the counterfeit product will be slightly taller, have a wider cap, and coarser ribbing on the cap then what is seen with authentic Alli.

People who believe they have received counterfeit Alli should not take the product and contact FDA's Office of Criminal Investigations (OCI) at 1-800-551-3989 or by visiting the OCI Web site. They can also contact GSK at 1 800 671 2554 if they believe they have purchased the counterfeit product.

People are encouraged to report adverse events that may be related to the use of these counterfeit products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program online [at www.fda.gov/MedWatch/report.htm], by phone 1-800-332-1088, or by returning the postage-paid FDA form 3500 [which may be downloaded from the MedWatch "Download Forms" page] by mail [to address on the pre-addressed form] or fax [1-800-FDA-0178].